Randomized trial of vitamin supplements in relation to vertical transmission of HIV-1 in Tanzania

Background: Observational studies suggest that poor nutritional status amon g HIV-infected pregnant women is associated with a higher risk of vertical transmission of HIV. Methods: We randomized 1083 pregnant women infected with HIV-1 in a double- blind, placebo-controlled trial to examine the effects of supplements of vi tamin A and/or multivitamins (excluding vitamin A) using a 2-x-2 factorial design. We report the effects of the supplements on HIV infection defined u sing polymerase chain reaction (PCR), or death up to 6 weeks postpartum. Results: Of babies in the multivitamin arm 38, (10.1%) were HIV-positive at birth compared with 24 (6.6%) in the no-multivitamin arm (relative risk [R R] = 1.54; 95% CI, 0.94-2.51; p =.08). Of babies born to mothers in the vit amin A arm, 38 (10.0%) were HIV-positive at birth compared with 24 (6.7%) i n the no-vitamin A arm (RR, 1.49; 95% CI, 0.91-2.43; p = 0.11). Neither mul tivitamins nor vitamin A had an effect on HIV status at 6 weeks among those who were HIV-negative at birth (RR = 1.04; 95% CI, 0.65-1.66; p = 0.88) an d (RR = 1.30; 95% CI, 0.80-2.09; p =.29, respectively). Similarly, neither supplement was associated with being either HIV-infected or dead at birth ( RR, 0.98; 95% CI, 0.76-1.27; p = .89 and RR, 1.01; 95% CI, 0.78-1.31; p = . 95, respectively). A beneficial effect of multivitamins on birth weight was limited to babies who were HIV-negative at birth; babies in the multivitam in arm weighed +94 g more compared with those in the no-multivitamin arm (p = .02). Among babies who were HIV-positive at birth, the corresponding dif ference was -31 g (p = .82). Conclusions: Vitamin A and multivitamins did not affect the risk of vertica l transmission of HIV in utero nor during the intrapartum and early breastf eeding periods. Multivitamins resulted in a significant improvement in birt h weight of babies who were HIV-negative at birth but had no effect among t hose who were HIV-positive. The effect of vitamin supplements on HIV transm ission through breast-feeding and on clinical progression of HIV disease is yet to be ascertained.